Through our +25 years of experience, we help our customers to develop their software as part of medical device, software as a medical device and data-driven healthcare solution – while taking all relevant requirements and the regulatory framework into account.

Digitalization is revolutionizing the future of healthcare. Both data-driven solutions and SW are playing an increasingly important role in this enabling novel ways to deliver healthcare. On the other hand, more stringent requirements to medical SW, including MDR with new classification rules for SW, are almost here. Companies will have to re-define their practices and processes to comply with the regulations, which is not an optional thing to do.

At Innokas Medical, Quality Driven Medical SW and Co-Creation are the cornerstones in helping you to bring your regulated medical SW and data-driven solution to the market.

“Co-Creation” of “Medical SW” covers your Software as part of Medical Device (Embedded SW), Software as a Medical Device (SaMD), or Data-Driven Healthcare solutions. “Quality Driven” signifies that the specific requirements and the regulatory framework are identified early on and the conformance is built effectively along the development life-cycle.

You have an idea of a Medical SW or Application? Let’s realize it together! Continue reading to learn more about our scalable service center model and service offering!

We are a full-service provider in all areas of medical software design and development for helping you to bring your regulated SW and data driven solution to the market. By co-creating with Innokas Medical, you’re able to concentrate on your own core expertise. Together with our talented partner- and subcontractor network, we complete your know-how by extending your R&D and QA&RA competences with our scalable service center model. We’re able to deliver the SW as a service or resource your on-site team with our experts. We’re happy to help you during each life cycle phase of your Medical Software and Application  development when needed.

• Over 60 professional design resources in Finland and in Sweden
• Development projects according to ISO 13485 QMS and FDA QSR
• Application life cycle management throughout the development project for full requirement traceability
• Technical file, DHF and DMR creation (e.g. MDD, IVDD, AIMD, MDR, IVDR, MDSAP, FDA 510(k))
• Understanding EU harmonized and FDA recognized standards
• Quality and Risk Management expertise
• Regulatory intelligence and submission experience